The March
2016 cover story in Healthcare Purchasing News, “IFUs: Essential
weapons against infections,” inspired one veteran healthcare executive and
long-time HPN reader to motivate us to take this issue to the next
– and most important – level. Manufacturer instructions for use (IFUs)
must be validated to be effective. Anything short of that will compromise
the quality of patient care delivered and ultimately may affect patient
mortality.

HPN
Senior Editor Rick Dana Barlow promptly engaged this healthcare executive
in a lengthy and illuminating email exchange that further explored the
issue of validated IFUs, which he referenced in his May 2016 Fast Foreward
column, “The V word,” and noted that he would post an edited transcript of
that email discussion as an exclusive on HPN Online. The discourse
follows.

Hello
Rick,

Jim
Schneiter

Let me
start by complimenting Healthcare Purchasing News on the
excellent cover on the March HPN issue, "IFUs:
Essential weapons against infections." Let me also compliment Kara
Nadeau on her extensive and informative article, "IFUs poised for
standards evolution, revolution."

My
question is why you didn't include the word "Validated" before IFUs on the
HPN cover so that the cover read, "Validated IFUs:
Essential weapons against infections.” I ask this important
question for several reasons:

First,
there have been numerous patient deaths over the past few years attributed
to endoscopes whose cleaning IFUs had not been validated. As a
result of these patient deaths, last summer the FDA cited
Pentax andFujifilm for failing to make
sure theirinstructions for cleaning the scopes were valid.

Second, the FDA issued new guidelines last
March that specifically require medical
device manufactures to "validate"
their cleaning IFUs. On page 22 of the FDA publication, “Reprocessing
Medical Devices in Health Care Settings: Validation Methods and Labeling
Guidance for Industry and Food and Drug Administration Staff,”the third paragraph states, “For class II and class III devices
and select class I devices, manufacturers must establish and maintain
procedures for validating the design of their device, which shall ensure
that the device conforms to defined user needs and intended uses, 21 CFR
820.30(g). Manufacturers must also establish and maintain procedures for
monitoring and control of process parameters for validated processes to
ensure that the specified requirements continue to be met, 21 CFR
820.75(b). Establishing procedures includes implementation, 21 CFR
820.3(k).

FDA interprets these regulations to require manufacturers to validate
the design, including reprocessing instructions, of reusable
devices to ensure that the device can be effectively reprocessed and
safely reused over its use life, as intended.

Third,
there are now several lawsuits, most notably at Lutheran General Hospital
in Park Ridge, IL, where the hospital is being sued by a deceased
patient’s family for using an endoscope (Pentax) whose cleaning IFUs
had notbeen validated. Over 38
patients became infected with CRE at Lutheran General from contaminated
scopes. This tragic story points out why the FDA, AAMI, Joint Commission,
AORN and the CDC are ALL pushing for the validation of manufacturers'
cleaning IFUs. As this case tragically demonstrates, following a
manufacturers' IFUs that have not been validated does not ensure
against patient harm.

Fourth,
while following a manufacturer’s cleaning IFUs is always a good idea (as
Kara's article points out), if the manufacturer’s IFUs have not been
validated using AAMI and ANSI validation protocols, there is no way to
ensure clean, sterile, moisture-free instruments on every reprocessing
cycle. The documented patient harm caused by devices whose IFUs had not
been validated at facilities like Lutheran General and Virginia Mason in
Seattle is just the tip of the iceberg. According to the CDC, over 30,000
patients die annually from surgical infections. Many of these deadly
infections are caused by contaminated instruments whose cleaning IFUs have
never been validated.

Fifth, as
the recent headlines over patient deaths have made it all too clear, a
lack of validated cleaning IFUs is a tremendous safety issue.
Healthcare facilities have a legal, ethical, financial and moral
obligation to use only instruments whose IFUs have been validated. As
Kara's article points out, IFUs are indeed poised for evolution and
revolution. In order to reduce patient risk and patient harm from
contaminated devices, the “revolution” must include “validated”
cleaning IFUs from every device manufacturer.

[Editor’s
Note: Jim Schneiter started his healthcare career in 1974 at American
Hospital Supply Corp. In 1986, Schneiter launched America’s MedSource
Inc., which develops, patents and then licenses healthcare devices and
products to various companies in the industry. Schneiter holds numerous
U.S. and foreign patents, patent applications, trademarks and copyrights
for medical devices he has invented and developed. Additionally, he has
been involved in numerous IDE filings, FDA product approvals, hospital and
office-based clinical trials, 510(k) filings and independent laboratory
studies.]

Hi Jim,

Thanks
for writing and for being such a loyal reader of Healthcare Purchasing
News.

You make
some valid points. Kara Nadeau quoted the venerable Charles Hughes on p.
22 referring to “validated IFUs.” On page 24, Marcia Frieze reinforces the
issue as well, and in the first paragraph under the subhead “Sticking to
Standards,” Kara references AAMI and AORN guidelines.

But the
REAL issue here in my opinion remains a boondoggle because it’s one of
accountability and responsibility… and not in a way you might think. Yes,
providers have a responsibility to use “validated” IFUs and device
manufacturers have a responsibility to issue “validated” IFUs for their
devices to be reprocessed, and the reprocessing equipment manufacturers
have a responsibility to “validate” that their technologies actually
achieve the kill rates (from disinfection to high-level disinfection to
sterilization) they claim. But the enduring question is WHO is the FINAL
authority qualified – and willing to accept responsibility – for declaring
these claims have been validated?

The FDA?
Unfortunately, the FDA relies on paperwork submitted by manufacturers
themselves, and to the best of my knowledge, doesn’t have or employ
[Underwriters Laboratories]-type labs and other resources to test and
verify claims. The federal agency just checks over paperwork submitted to
“clear” something for marketing and technically doesn’t “approve” products
for use. If FDA were more involved directly, then it would be subject to
lawsuits involving negligence. When the FDA calls for “validated” IFUs and
the manufacturers only provide IFUs without evidence of validation by some
FDA-accepted/certified validation organization does the federal agency
prevent the devices from going to market? Well, if they did we would not
be writing and publishing stories like this, and patients (and their
families and friends) wouldn’t be suffering.

Further,
by reprocessing these devices providers have been tagged as “remanufacturers,”
which can place them in a similar boat as the manufacturers themselves,
but the FDA hasn’t shut down SPD departments where questionable practices
led to the incidents cited in the HPN article and others.

AAMI
and/or AORN? These two organizations issue “guidelines” and “recommended
practices” that protect them from legal recrimination and financial
restitution.

Ultimately, the healthcare industry voluntarily must agree to follow some
certification/validation-granting body – Joint Commission perhaps? – that
might subcontract actual scientific testing to an Underwriters
Laboratories-like organization. Then the FDA would have to agree that the
Joint Commission, for example, is the certifying/validating body of
record. Furthermore, if suppliers and providers alike are found to be
operating in violation of the certified/validated IFUs as determined by
the universally accepted governing body and “approved” by the FDA then
another government agency – as in CMS – could deny reimbursement to those
providers for non-compliance and violations (which would be in addition to
the suppliers and providers being subjected to operational malpractice
lawsuits stemming from patient harm).

Once
again, it all comes down to standards. Who sets them? Who agrees to them?
How do you make them stick? How do you enforce compliance?

Thanks
for reading and sharing your thoughts. We now have fodder for future
coverage and stories.

RDB

Hello
Rick,

Thank you
for your lengthy, thoughtful response to my email. Let me address the
points you made in the order in which you made them: